Effectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse

Relapse Clinical Trial

Official title:

Effectiveness of Two Types of Fixed Lingual Retainers in Preventing Mandibular Incisor Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03881813
• Other study ID #: DUHS/DR-0/2017/327
• Status: Completed
• Phase: N/A
• Start date: November 12, 2017
• Est. completion date: March 15, 2019

Study information

• Verified date: March 2019
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study evaluates effectiveness of two types of fixed retainers in post orthodontic patients. Half of the subjects are randomly allocated Group 1 retainer (FRC) and other half is given Group 2 retainer (MSW) and followed for a period of one year.

Description:

54 subjects were recruited and divided into two groups by random allocation. Consents were obtained . Group 1 received fiber reinforced composite retainer and group 2 received multistranded stainless steel wire retainer. The patients were recalled at every three months interval for a period of 12 months. They were evaluated for number of fractures, failure pattern based on adhesive remnant index and relapse tendency by measuring little's irregularity index.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 30 Years

Eligibility

Inclusion Criteria:

• Subjects who have completed fixed appliance orthodontic treatment.

• Subjects who have signed the consent forms.

• Subjects who have accepted the terms and conditions of visiting after every three months for one year.

• Non extraction cases in the mandibular arch with no IPR.

• Patients without caries/ restoration/ fracture on the lower anterior teeth.

• Patients with healthy periodontium with no periodontal disease at that time.

Exclusion Criteria:

• Presence of syndrome or systemic disease.

• Patients taking medications/ drugs.

• Patients with poor oral hygiene.

• Patients with congenitally absent/ missing anterior teeth in the mandibular arch.

• Patients with habit of clenching/ bruxism.

• Patients with history of betel nut chewing.

• Presence of occlusal interferences.

Related Conditions & MeSH terms

• Recurrence
• Relapse

Intervention

Device:
• Orthodontic retainers
Orthodontic retainers were bonded on the lower teeth of the subjects after fixed orthodontic treatment and were evaluated for their effectiveness for the followup of one year.

Locations

Country	Name	City	State
Pakistan	Dow University Of Health Sciences	Karachi

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse tendency	It was measured using Little's irregularity index	12 months
Secondary	Bond failure	Number of bond failure was assessed at each visit.	12 months
Secondary	Failure Pattern	Type of failure pattern was assessed based on Adhesive remnant index.	12 months